TYLENOL® with Codeine CIII (acetaminophen and codeine phosphate) tablets

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D), codeine phosphate (UNII: GSL05Y1MN6) (codeine anhydrous - UNII:UX6OWY2V7J)

Предлага се от:

Janssen Pharmaceuticals, Inc.

INN (Международно Name):

acetaminophen

Композиция:

acetaminophen 300 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

TYLENOL® with Codeine (acetaminophen and codeine phosphate) tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS ), reserve TYLENOL® with Codeine tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - Have not provided adequate analgesia, or are not expected to provide adequate analgesia, - Have not been tolerated, or are not expected to be tolerated. TYLENOL® with Codeine is contraindicated for: - All children younger than 12 years of age (see WARNINGS ). - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ). TYLENOL® with Codeine is contraindicated in patients with: - Significant respiratory depression (see WARNINGS ). - Acute or severe bronchial asthma in an unmonitor

Каталог на резюме:

TYLENOL® with Codeine (acetaminophen and codeine phosphate) No. 3 Tablets contain acetaminophen 300 mg and codeine phosphate 30 mg. The tablets are white, round, flat-faced, beveled-edged, and imprinted "McNEIL" on one side and "TYLENOL CODEINE" and "3" on the other side. TYLENOL® with Codeine (acetaminophen and codeine phosphate) No. 4 Tablets contain acetaminophen 300 mg and codeine phosphate 60 mg. The tablets are white, round, flat-faced, beveled-edged, and imprinted "McNEIL" on one side and "TYLENOL CODEINE" and "4" on the other side. TYLENOL® with Codeine Tablets are supplied as follows: TYLENOL® with Codeine No. 3 bottle of 100 tablets – NDC 50458-513-60 TYLENOL® with Codeine No. 3 bottle of 1000 tablets – NDC 50458-513-80 TYLENOL® with Codeine No. 4 bottle of 100 tablets – NDC 50458-515-60 TYLENOL® with Codeine No. 4 bottle of 500 tablets – NDC 50458-515-70 Store TYLENOL® with Codeine tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Dispense in tight, light-resistant container as defined in the USP. Store TYLENOL® with Codeine tablets securely and dispose of properly (see PRECAUTIONS/ Information for Patients ). Keep out of the reach of children.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Janssen Pharmaceuticals, Inc.
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MEDICATION GUIDE
TYLENOL® (TAHY-LUH-NAWL) WITH CODEINE TABLETS, CIII
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
TYLENOL® with Codeine tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage mild to
moderate pain, when other pain treatments such as non-opioid pain
medicines do not treat your pain
well enough or you cannot tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose
correctly as prescribed, you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about TYLENOL® with Codeine tablets:
•
Get emergency help right away if you take too much TYLENOL® with
Codeine tablets (overdose).
When you first start taking TYLENOL® with Codeine tablets, when your
dose is changed, or if you
take too much (overdose), serious or life-threatening breathing
problems that can lead to death may
occur.
•
Taking TYLENOL® with Codeine tablets with other opioid medicines,
benzodiazepines, alcohol, or
other central nervous system depressants (including street drugs) can
cause severe drowsiness,
decreased awareness, breathing problems, coma and death.
•
Never give anyone else your TYLENOL® with Codeine tablets. They could
die from taking it.
Selling or giving away TYLENOL® with Codeine tablets is against the
law.
•
Store TYLENOL® with Codeine tablets securely, out of sight and reach
of children, and in a location
not accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
•
Do not give TYLENOL® with Codeine tablets to a child younger than 12
years of age.
•
Do not give TYLENOL® with Codeine tablets to a child younger than 18
years of age after surgery
to remove the tonsils and/or adenoids.
•
Avoid giving TYLENOL® with Codeine tablets to children between 12 to
18 years of age who have
risk factors for breathing problem

Данни за продукта

TYLENOL WITH CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
JANSSEN PHARMACEUTICALS, INC.
----------
TYLENOL
WITH CODEINE
CIII
(ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLETS
®
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF
CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY
DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME;
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES;
HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
TYLENOL WITH CODEINE EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF
OPIOID ADDICTION,
ABUSE AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH
PATIENT'S RISK PRIOR
TO PRESCRIBING TYLENOL WITH CODEINE TABLETS, AND MONITOR ALL PATIENTS
REGULARLY FOR THE
DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS (SEE WARNINGS).
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND
MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A REMS FOR
THESE PRODUCTS
(SEE WARNINGS). UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED
OPIOID ANALGESIC PRODUCTS MUST MAKE REMS COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS
RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION
GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
TYLENOL WITH CODEINE TABLETS. MONITOR FOR RESPIRATORY DEPRESSI